Health trends
The US Food and Drug Administration (FDA) commissioner, Margaret A. Hamburg, MD, said last Friday she is revoking the agency's approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.
Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney, and brain cancer (glioblastoma multiforme).
"This was a difficult decision. FDA recognises how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use," Dr Hamburg said. "After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumour growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."
Avastin's risks include severe high blood pressure; bleeding and haemorrhaging; heart attack or heart failure; and the develop-ment of perforations in different parts of the body such as the nose, stomach, and intestines.
Leukaemia treatment approved
The US Food and Drug Administration recently approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukaemia (ALL) who have developed an allergy (hypersensitivity) to E. coli-derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
Acute lymphoblastic leukaemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow.
